BILL ALSO INCLUDES STEARNS’ MEASURE FOR FDA CONSULTATION WITH OUTSIDE EXPERTS ON RARE DISEASES

WASHINGTON, MAY 10, 2012 – The House Energy and Commerce Committee today approved legislation including the provisions from two bills proposed by Rep. Cliff Stearns (R-FL).  During consideration of H.R. 5651, the Food and Drug Administration (FDA) Reform Act, the provisions of two bills sponsored by Stearns, H.R. 4132 and H.R. 4156, were added to the FDA Reform Act.

Stearns, joined by Rep. Ed Towns (D-NY), offered H.R. 4132, the Faster Access to Specialized Treatment (FAST) Act, which would update and modernize the Accelerated Approval statute to reflect two decades worth of medical sciences that has occurred since Accelerated Approval was first created. Stearns explained, “The FAST Act will help the FDA to implement broadly effective processes for the expedited development and review of innovative new medicines addressing serious or life-threatening diseases by using modern scientific tools.  This may result in fewer, smaller or shorter clinical trials without compromising FDA’s existing high standards to protect patients.”    

The bill today also included the language of H.R. 4156, the Expanding and Promoting Expertise in Review of Rare Treatments (EXPERRT) Act.  Said Stearns, “The EXPERRT Act will make it easier for the FDA to access the outside expertise they need to understand the science behind new drugs intended to treat cystic fibrosis and other rare diseases and subtypes of diseases.”  Stearns, Co-Chair of the Cystic Fibrosis Caucus, joined his other co-chairs in offering the EXPERRT Act.